To reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults

For the symptomatic treatment of focal spasticity affecting the upper and lower limbs in adults

For the symptomatic treatment of lower limb spasticity in pediatric patients 2 years of age and older

Limited data in subjects >65 years of age. Not recommended for use in pediatric patients (<18 years of age) in the treatment of upper limb spasticity or cervical dystonia.

Contraindications:

Patients with infection at the proposed injection sites

Known allergy to cow’s milk protein

Hypersensitive to abobotulinumtoxinA or any of the ingredients in the formulation

Serious warnings and precautions:

Dosing units: Units representing DYSPORT THERAPEUTIC™ activity are not interchangeable with other products.

Dosing and administration: Follow the recommended dosage and frequency of administration for DYSPORT THERAPEUTIC™.

Distant spread of toxin effect: All botulinum toxin products, including DYSPORT THERAPEUTIC™, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. Swallowing and breathing difficulties can be life-threatening and fatal, with the risk being greater in those with underlying conditions that would predispose them to these symptoms.

Caution in patients with inflammation at the injection site, deep dermal scarring or thick sebaceous skin

Caution in adults with lower limb spasticity, especially the elderly, who may be at increased risk of falls

Risk to pregnant women is unknown. Use only if the benefits justify any potential risk

Not recommended during lactation

For more information:

Please consult the Product Monograph for important information relating to adverse reactions, drug interactions and dosing. The Product Monograph is also available by calling Ipsen Medical Information at 1-855-215-2288.